Quality Systems

Michaela Doláková is chief microbiologist at SCTbio.

Veronika Horková is microbiologist at SCTbio.

Klára Sochorová is senior quality compliance manager at SCTbio.

Daniela Rožková is chief technology officer at SCTbio.

Articles

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

Rapid Sterility Methods for CAR T-cell Therapies

Ramesh Raju Mavuleti*, rrajum@gmail.com, is head of operations, Validation Services India, at Merck Life Sciences Pvt, Ltd.

K. Vasantakumar Pai, PhD , is professor and chairman, PG Department of studies & research in Industrial Chemistry, Kuvempu University

K. Sreedhara Ranganath Pai, PhD, is professor, epartment of Pharmacology, Manipal Academy of Higher Education

Subhasis Banerjee, PhD, is principal technical application expert, Bioprocessing APAC, at Merck Life Sciences Pvt, Ltd.

Somasundaram Gopalakrishnan, is senior consultant, Global Biopharm Center of Excellence, Merck Pte. Ltd.

Tathagata Ray is Area Manager, Process Development at Millipore India Pvt. Ltd (India).

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

is quality unit lead and technical director, Bristol Myers Squibb, São Paulo, Brazil.

is director CMC Technical Advocacy and Policy, Merck Sharp and Dohme, LLC, Horsham, PA, USA.

is chief pharmaceutical officer, Sanofi Vaccines, Lyon, France.

is quality assurance director, Merck & Co. Inc., Rahway, NJ, USA.

is scientific director, Johnson & Johnson Innovative Medicine, Leiden, The Netherlands.

is head of External Affairs Europe, Amgen (Europe) GmbH, Rotkreuz, Switzerland.

is global SME Quality Advocacy, Vaccines Global Quality, GSK, Wavre, Belgium.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products

Feliza Mirasol is the science editor for 

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

Shoring Up Data Integrity Practices

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.



New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications.

FDA Releases Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

The annual report details OPQ’s quality assurance work for 2023 including its support for the creation of guidance documents.

FDA’s Office of Pharmaceutical Quality Reports on 2023 Quality Assessments

Valerie Mulholland is a PhD Candidate, Pharmaceutical Regulatory Science Team (PRST), Technological University Dublin.

Anne Greene, PhD, is director PRST, Technological University Dublin.

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

The company is recalling one lot of the product because of the potential presence of silicone particulates.

Quality Assurance/Quality Control